Effects of Pain, Disability and Cervicokinesthesia After Cervical Manipulation

Effects of Pain, Disability, Widespread Pressure Pain Sensitivity, and Cervicokinesthesia After Cervical Manipulation in Patients With Mechanical Neck Pain

Cervical spine manipulation has been found to be effective in patients with mechanical neck pain. Discrepancies exist on the side of manipulation and the placebo effect of this manual intervention. In addition, some authors have proposed that spinal manipulation can alter proprioception of the cervical spine. The aim of this study will be to investigate the effects of cervical spine manipulation on pain, disability, widespread pressure pain sensitivity, and cervicokinethesia in patients with mechanical neck pain.

Study Overview

• Status: Completed
• Conditions: Neck Pain
• Intervention / Treatment: Other: Right Cervical Manipulation; Other: Left Cervical Manipulation; Other: Sham Cervical Manipulation

Detailed Description

Cervical spine manipulation has been found to be effective in patients with mechanical neck pain. Discrepancies exist on the side of manipulation and the placebo effect of this manual intervention. In addition, some authors have proposed that spinal manipulation can alter proprioception of the cervical spine. The aim of this study will be to investigate the effects of cervical spine manipulation on pain, disability and cervicokinethesia in patients with mechanical neck pain. Patients will receive cervical spine manipulation in either right or left side of the neck and will be assessed on pain intensity, neck-related disability, widespread pressure pain sensitivity, and cervicokinethesia by an assessor blinded to the allocation group.

• Study Type: Interventional
• Enrollment (Actual): 55
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Madrid
    • Alcorcon, Madrid, Spain, 28921
      • César Fernández-de-las-Peñas

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

- Generalized neck-shoulder pain with symptoms provoked by neck postures, neck movement, or palpation of the cervical musculature.

Exclusion Criteria:

• any contraindication to manipulation, e.g., positive extension-rotation test;
• whiplash injury;
• previous cervical surgery;
• cervical radiculopathy or myelopathy;
• diagnosis of fibromyalgia syndrome;
• having undergone spinal manipulative therapy in the previous 6 months;
• less than 18 or greater than 65 years of age.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Right Cervical Manipulation; Patients assigned to this group will receive a cervical spine manipulation targeting the C3/C4 segment on the right side.	Other: Right Cervical Manipulation; We will use a high-velocity, mid-range, left rotational force to the right articular pillar of C3, on the right articular pillar of C4 with the patient in supine, with left rotation and right side-bending.
Experimental: Left Cervical Manipulation; Patients assigned to this group will receive a cervical spine manipulation targeting the C3/C4 segment on the left side.	Other: Left Cervical Manipulation; We will use a high-velocity, mid-range, left rotational force to the left articular pillar of C3, on the left articular pillar of C4 with the patient in supine, with right rotation and left side-bending.
Active Comparator: Sham Cervical Manipulation; Patients assigned to this group will receive a sham cervical spine manipulation targeting the C3/C4 segment on both sides. No therapeuthic thrust will be applied.	Other: Sham Cervical Manipulation; The sham procedure will simulate C3/C4 manipulation in both sides without any therapeutic thrust

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in cervical kinesthetic sense before and after the intervention	The joint position sense error (JPSE) will be calculated to determine cervicokinethesia	Baseline and 15 minutes after the intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in disability before and after the intervention	The Neck Disability Index (NDI) will be used to determine neck-related disability	Baseline and one week after the intervention
Changes in neck pain intensity before and after the intervention	An 11 points numerical pain rate scale (NPRS, 0-10) will be used to assess the intensity of neck pain	Baseline and one week after the intervention
Changes in widespread pressure pain sensitivity before and after the intervention	Pressure pain thresholds will be assessed over C5/C6 zygapophyseal joints and the tibialis anterior muscle	Baseline and 15 minutes after the intervention

Collaborators and Investigators

• Sponsor: Universidad Rey Juan Carlos
• Investigators: Principal Investigator: CESAR FERNANDEZ-DE-LAS-PEÑAS, PT, PhD, Universidad Rey Juan Carlos

Study record dates

Study Major Dates

• Study Start: December 1, 2015
• Primary Completion (Actual): November 1, 2016
• Study Completion (Actual): December 1, 2016

Study Registration Dates

• First Submitted: December 30, 2015
• First Submitted That Met QC Criteria: January 4, 2016
• First Posted (Estimate): January 5, 2016

Study Record Updates

• Last Update Posted (Estimate): December 9, 2016
• Last Update Submitted That Met QC Criteria: December 8, 2016
• Last Verified: December 1, 2016

More Information

Terms related to this study

• Keywords: Spinal manipulation; Cervical spine
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Neck Pain
• Other Study ID Numbers: URJC2015-161120155015

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO